Medical journal slams Ottawa for cutting off post-trial heroin

Mike Hager, Vancouver Sun12.09.2013

The federal health minister has breached the international medical ethical standards by stopping participants in a Downtown Eastside clinical study from getting post-trial access to heroin, according to a scathing editorial in Canada’s leading medical journal.

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The federal health minister has breached international medical ethical standards by stopping participants in a Downtown Eastside clinical study from getting post-trial access to heroin, according to a scathing editorial in Canada’s leading medical journal.

On Oct. 3, Health Minister Rona Ambrose announced that participants finishing Providence Health Care’s radical trial had three months to find alternative treatments to injectable heroin, despite already having approval for special post-trial access to injectable heroin. The minister’s announcement goes against a section of the World Medical Association’s Helsinki Declaration on human research ethics, according to Dr. John Fletcher, the Canadian Medical Association Journal’s editor-in-chief.

“Whatever we may think of people with chronic addiction to heroin, they are marginalized, vulnerable, have poor health and are often socio-economically disadvantaged ...” Fletcher wrote. “As research participants, they should be protected, not exploited.

“Whatever we may think of our government’s prerogative to set policy and take a lead, its action broke an ethical obligation of two of its own federal bodies, CIHR (Canadian Institutes of Health Research) and Health Canada.”

Fletcher added that Ambrose’s announcement “swept aside the careful planning” of researchers with those two bodies and the University of British Columbia who are comparing the effectiveness of diacetylmorphine — prescription heroin — and an oral painkiller known as hydromorphone for treating severe heroin addiction.

No one from Health Canada was available for comment Sunday, but Ambrose has said her department’s decision to provide heroin to certain addicts under the special access program — designed to allow patients in exceptional cases to get medications normally not allowed in Canada — is wrong and won’t happen again. Ambrose has argued that the decision will “protect the integrity” of that access program by denying doctors the right to use it to provide illegal drugs like heroin or cocaine to patients.

The Harper government is strongly opposed the Downtown Eastside’s Insite supervised injection site — which marked its 10-year anniversary in September — and lost a long legal fight to close it.

“The time to take a strong policy stance on injectable heroin and to say ‘no’ to this research was before it was funded and before the first patient was enrolled,” Fletcher wrote in his editorial. “Having funded this study and approved post-trial access to treatment, the government should see this through.

“The special access provisions should continue for everyone in this trial who needs them.”

“To me it’s very important to have an organization like the CMAJ come out on that, because it’s a really well-respected journal and it’s scientists and doctors,” Bernstein said.

However, only a judge is likely to convince the federal government to reverse its decision, Bernstein said.

“It’s not a matter of the federal government just not knowing that it works or not knowing the circumstances,” Bernstein said. “I think they’ve taken an ideological position with their regulations, so I don’t think anything is going to upend that until we get a court decision.”

The SALOME study is testing whether the opioid hydromorphone is as effective as heroin in stabilizing the lives of long-term drug users who have not responded to other treatments, such as methadone and abstinence-based programs. Using heroin to treat relapsed heroin users is more cost-effective than traditional methadone maintenance, according to a study based on North America’s only clinical trial of medically prescribed heroin.

Addicts in methadone treatment generate an average lifetime cost to society of $1.14 million, compared to $1.09 million for an addict in heroin treatment, according to Aslam Anis, director of the Centre of Health Evaluation and Outcomes Sciences.

Bernstein said he hopes an injunction hearing, which is part of Pivot’s overall legal challenge to the federal government outlawing SALOME’s heroin prescriptions, will happen sometime in January.

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